Riokast-10
Montelukast Sodium • DAR No.: 431-003-044
Riokast-10
Montelukast Sodium
Leukotriene Receptor Antagonists (Leukotriene receptor antagonists)
Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLT1). The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma & allergic rhinitis, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.
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Product Specifications
Detailed clinical and therapeutic information for healthcare professionals.
Description
Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLT1). The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma & allergic rhinitis, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.
Composition & Active Ingredients
Each film coated tablet contains Montelukast Sodium USP equivalent to Montelukast 10 mg.
Indications & Therapeutic Uses
Montelukast Sodium is indicated for: Prophylaxis and chronic treatment of asthma Acute prevention of Exercise-Induced Bronchoconstriction (EIB) Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis.
Dosage & Administration
Adults and adolescents with asthma or seasonal allergic rhinitis: The dosage for adults and adolescents 15 years of age and older: Montelukast 10 mg tablet once daily. Pediatric patients with asthma or seasonal allergic rhinitis: The dosage for pediatric patients 6 to 14 years of age: Montelukast 5 mg tablet once daily. The dosage for pediatric patients 2 years to 5 years of age: Montelukast 4 mg tablet once daily. The dosage for pediatric patients 6 months to 5 years of age: Montelukast 4 mg oral granules once daily. This can be administered either directly in the mouth, or mixed with a spoonful of cold water or soft food at room temperature Use in the pediatric patient: The safety and efficacy of Montelukast have been established in adequate and well-controlled studies in pediatric patients with asthma 6 months to 14 years of age. Safety and efficacy profiles in this age group are similar to those seen in adults. Hepatic Insufficiency: No dosage adjustment is required in patients with mild-to-moderate hepatic insufficiency. Renal Insufficiency: No dosage adjustment is recommended in patients with renal insufficiency. Elderly use: The pharmacokinetic profile and the oral bioavailability of a single 10-mg oral dose of montelukast are similar in elderly and younger adults. The plasma half-life of montelukast is slightly longer in the elderly. No dosage adjustment in the elderly is required.
Drug Interaction
Montelukast has been administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma with no apparent increase in adverse reactions. In drug interaction studies, the recommended clinical dose of Montelukast did not have clinically important effects on the pharmacokinetics of the following drugs: theophylline, prednisone, prednisolone, oral contraceptives (norethindrone 1mg/ethinyl estradiol 35mcg), terfenadine, digoxin, and warfarin. Although additional specific interaction studies were not performed, Montelukast was used concomitantly with a wide range of commonly prescribed drugs in clinical studies without evidence of clinical adverse interactions. These medications included thyroid hormones, sedative hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines and decongestants. Phenobarbital, which induces hepatic metabolism, decreased the AUC of Montelukast approximately 40% following a single 10mg dose of Montelukast. No dosage adjustment for Montelukast is recommended. It is reasonable to employ appropriate clinical monitoring when potent cytochrome P450 enzyme inducers, such as phenobarbital or rifampin, are co-administered with Montelukast.
Side Effects
Common: Diarrhoea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, upper respiratory tract infection. Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders. Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.
Contraindications
Montelukast is contraindicated in patients who are hypersensitive to any component of this product.
Storage Conditions
Store in a cool (below 30°C) and dry place, protected from light & moisture. This medicine should not be used after the expiry date (EXP) shown on the pack. Keep all medicine out of reach of children.
Precaution & Caution
Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Patients should be advised to have appropriate rescue medication available. Therapy with Montelukast can be continued during acute exacerbations of asthma. While the dose of inhaled corticosteroid may be reduced gradually under medical supervision, Montelukast should not be abruptly substituted for inhaled or oral corticosteroids. Montelukast should not be used as monotherapy for the treatment and management of exercise induced bronchospasm. Patients with known aspirin sensitivity should continue avoidance of aspirin or non-steroidal anti-inflammatory agents while taking Montelukast. Although Montelukast is effective in improving airway function in asthmatics with documented aspirin sensitivity, it has not been shown to truncate bronchoconstrictor response to aspirin and other non-steroidal anti-inflammatory drugs in aspirin-sensitive asthmatic patients.
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